BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ITIND, WITH SNARE, STERILE

    MDR report key: 19121026 · Received April 16, 2024

    Report

    Report Number
    2429304-2024-00225
    Event Type
    Injury
    Date Received
    April 16, 2024
    Date of Event
    March 6, 2024
    Report Date
    April 16, 2024
    Manufacturer
    MEDI-TATE LTD.
    Product Code
    KOE
    UDI-DI
    07290015518062
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IT WAS INITIALLY REPORTED, A PATIENT WHO HAD THE SUBJECT DEVICE IMPLANTED DEVELOPED A DRUG RESISTANT URINARY TRACT INFECTION (UTI), HAD TO BE GIVEN INTRAVENOUS (IV) ANTIBIOTICS, AND WAS HOSPITALIZED. THE PROVIDER LATER REPORTED THAT THE DEVICE WAS IMPLANTED ON (B)(6) 2024, AND EXPLANTED ON (B)(6) 2024. FIVE DAYS AFTER EXPLANT, THE PATIENT STARTED EXPERIENCING CHILLS, WEAKNESS, NAUSEA, AND ALTERED MENTAL STATUS. THEY PRESENTED TO THE HOSPITAL AND WAS FOUND TO HAVE A MULTI DRUG RESISTANT UTI WITH A URINE CULTURE POSITIVE FOR MORGANELLA MORGANII. THE PATIENT WAS TREATED WITH ERTAPENEM ANTIBIOTIC THERAPY FOR 7 DAYS WITH RESOLUTION OF SYMPTOMS AS OF POST OPERATIVE CHECK ON (B)(6) 2024. OF NOTE, THE PATIENT HAD A NEGATIVE PRE-IMPLANT URINE CULTURE AND RECEIVED SINGLE-DOSE IV ANTIBIOTICS AT THE TIME OF PRE-IMPLANTATION AND EXPLANTATION. THERE WERE NO REPORTS OF FURTHER PATIENT HARM. DUE TO SYSTEM LIMITATION FOR THE D2 FIELD, THE MORE ACCURATE DEVICE PRODUCT CODE IS BEING ENTERED HERE: QKA - TEMPORARILY-PLACED URETHRAL OPENING SYSTEM FOR SYMPTOMS OF BENIGN PROSTATIC HYPERPLASIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1231328 ITIND, WITH SNARE, STERILE ITIND SYSTEM KOE MEDI-TATE LTD. WA2ITA00 07290015518062

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| H